AbbVie announced the start of a robust Phase 3 clinical trial to analyze the use of ABT-494 – an investigational oral selective JAK1 inhibitor – in the treatment of rheumatoid arthritis (RA). The trial will enroll adults who have never taken methotrexate and patients with inadequate responses to conventional disease-modifying anti-rheumatic drugs (DMARDs).
“We continue to leverage our expertise in rheumatology and immunology to address the unmet needs of patients living with immune-mediated diseases, including those who fail to respond to the current standard of care,” AbbVie Vice President of Pharmaceutical Development Scott Brun, M.D., said in a press release. “We are optimistic that our robust Phase 3 clinical trial program, which dosed the first patient in December, will help us further understand the therapeutic potential of ABT-494 across multiple patient populations and achieve our goal of providing patients with best-in-class treatment options.”
Phase 2 ABT-494 clinical trials, BALANCE-1 and BALANCE-2, demonstrated the efficacy of ABT-494 across 6 mg, 12 mg, and 18 mg doses twice a day, and 24 mg doses once-daily in patients with RA who had reported an inadequate response to prior anti-tumor necrosis factor (TNF-IR) or to methotrexate (MTX-IR) treatment.
One of the five Phase 3 trials included in the program, the SELECT-COMPARE clinical trial is a double-blind, placebo- and active-controlled study designed to evaluate the safety and efficacy of ABT-494 in combination with MTX in adults with moderate-to-severe RA who have experienced an inadequate response to prior treatment with MTX.
The first trial is scheduled for 48 weeks with a target number of 1,500 patients and, together with the second Phase 3 trial (SELECT-NEXT), is now open for enrollment in the U.S. All studies will evaluate the safety, tolerability and efficacy of ABT-494, including American College of Rheumatology (ACR) improvement criteria and levels of disease activity.
The three remaining Phase 3 trials will soon begin enrolling participants who have an inadequate response to biologics and those who have never taken MTX.
Occupational exposure to textile dust more than doubles the risk of developing rheumatoid arthritis, according to a study published in the Annals of the Rheumatic Diseases titled “Occupational exposure to textile dust increases the risk of rheumatoid arthritis: results from a Malaysian population-based case–control study.”